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TruClear 72205051

by Covidien LP

Ref 72205051

TruClear 72205051 is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0763000B000192088), cleared under FDA 510(k) K180496 on 29 Aug 2018 and listed in FDA GUDID since 21 Dec 2018 (UDI-DI 10884521750203), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180496

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000192088 Basic UDI-DI 10884521750203UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521750203 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180496 Date29 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000192088 registered 5 Oct 2026 Active
  • FDA 510(k) K180496 decided 29 Aug 2018 Active
  • FDA GUDID UDI-DI 10884521750203 listed 21 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180496
  2. Listed FDA GUDID 10884521750203
  3. Registered EUDAMED 0763000B000192088

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TruClearTM EUDAMED
TruClear GUDID
Generic name
Rigid optical hysteroscope
Device name
TruClear Elite Hysteroscopic Seal
Model / reference
72205051
Primary DI / UDI-DI
10884521750203
Basic UDI-DI
0763000B000192088
510(k) Number
FDA product code
HIH
EMDN code
Z12020707 Resectoscopes
GMDN term
Rigid optical hysteroscope
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.1690
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 10884521750203: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 10884521750203: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rigid optical hysteroscope

Cleared under the same submission (K180496)

and 2 more cleared under K180496

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

Other devices from Covidien LP

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    Class II

  • Shiley 110860

    Class II

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    Class II

  • Shiley 110870

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See all devices from Covidien LP →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)